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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 1-119
Standard
ISO  14408 Third edition 2016-02-15
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
Scope/Abstract
ISO 14408:2016 specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5730 Tracheal tube. Tube, Tracheal (W/Wo Connector) Class 2 BTR
§868.5730 Tracheal tube. Tube, Tracheal, Reprocessed Class 2 NMA
§868.5740 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 CBI
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Annie Abraham
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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